ICON 20 HCG PREGNANCY TEST
Received Feb 1, 2023 · Event occurred Dec 15, 2022
Report MW5114626 · MDR key 16282809
Device
Generic name
Visual, Pregnancy Hcg, Prescription Use
Manufacturer
Beckman Coulter, Inc.Model number
395097Catalog number
B3167-50
Lot number
032H11
Product problems
- False Positive Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
HIGH RATE OF FALSE POSITIVE RESULTS ON BECKMAN COULTER ICON 20 HCG KITS, LOT 032H11. FALSE POSITIVES HAVE OCCURRED ON EIGHT DIFFERENT PATIENTS. DATES OF OCCURRENCE WERE (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2023, AND (B)(6) 2023. RESULTS WERE DETERMINED TO BE FALSE POSITIVES BASED ON REPEATING THE URINE ON ANOTHER LOT OF ICON 20 HCG KITS, RUNNING THE PATIENTS' SERUM HCG (BECKMAN ACCESS 2), AND/OR ULTRASOUND. PATIENT AGES RANGE FROM 17 TO 45 YEARS. PATIENTS INCLUDE 7 CIS FEMALES AND 1 TRANSGENDER MALE. APPROXIMATELY 451 TESTS HAVE BEEN PERFORMED ON THIS LOT BETWEEN TWO LOCATIONS, (B)(6). APPROXIMATE FALSE POSITIVE RATE IS (B)(4). REFERENCE REPORTS: MW5114623, MW5114624, MW5114625, MW5114627, MW5114628, MW5114629, MW5114630.